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Pic/S Good Practice Guidelines For Blood Establishments and Hospital Blood Banks
Pic/S Good Practice Guidelines For Blood Establishments and Hospital Blood Banks
Pic/S Good Practice Guidelines For Blood Establishments and Hospital Blood Banks
PE 005-4
1 June 2021
© PIC/S 2021
Reproduction prohibited for commercial purposes.
Reproduction for internal use is authorised,
provided that the source is acknowledged.
e-mail: info@picscheme.org
web site: https://www.picscheme.org
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B. INTRODUCTION
Blood components are essential life-saving components widely used in transfusion for
severely injured people or critically ill patients. Allied to this is a heightened public
awareness and expectation of the quality and safety of these products. Therefore, high
standards of quality and safety of blood components have to be assured. These high
standards can only be achieved by applying the principles of Good Manufacturing
Practices (GMP) during the collection, processing, testing, storage and distribution of
these products.
The PIC/S Expert Circle on Blood undertook in 1996 the task of drafting a specific GMP
guide for blood establishments and blood components. The PE 005 had to be read in
conjunction with the general PIC/S GMP Guide (PE 009).
Starting in 2010, a joint European Union Commission/ European Directorate for the
Quality of Medicines (EU/EDQM) working group undertook the elaboration of standards
for guidelines on good practices for blood establishments and hospital blood banks
based on the principles of GMP. They were published in the 19th edition of the Guide to
the preparation, use and quality assurance of blood components.
These Good Practice Guidelines (GPG) fully reflect the detailed principles and guidelines
of GMP applied for pharmaceutical products as long as they are relevant for blood
establishments and their quality systems. Accordingly, they are recognised as
appropriate GMP standards also for the collection and testing of plasma for fractionation,
as mentioned in Annex 14 of the PIC/S GMP Guide (PE 009).
In 2018, PIC/S decided to update PE 005 by aligning it with the EU/EDQM GPG for the
sake of harmonisation globally for GMP requirements for collection, processing, testing,
storage and distribution of blood and blood components, whatever their intended use.
This Guide is not intended to place any restraint upon the development of new concepts
or new technologies, which have been validated and provide a level of compliance at
least equivalent to the standards set out in this Guide.
D. SCOPE
The standards set out herein apply to collection, processing, testing, storage and
distribution of blood and blood components (including plasma for fractionation) intended
either for transfusion or as starting material for further processing or manufacture of
plasma-derived medicinal products. It applies to blood establishments and to hospital
blood banks (hereinafter also referred to as 'organisation').
1. GENERAL PRINCIPLES
3. PREMISES
3.1. General
3.1.1. Premises including mobile sites should be located, constructed, adapted
and maintained to suit the activities to be carried out. They should enable
work to proceed in a logical sequence so as to minimize the risk of errors,
and should allow for effective cleaning and maintenance in order to
minimize the risk of contamination.
3.1.2. Lighting, temperature, humidity and ventilation should be appropriate and
such that they do not adversely affect (directly or indirectly) blood
components during their processing and storage, or the accurate
functioning of equipment.
3.1.3. Premises should be designed and equipped so as to afford protection
against the entry of insects or other animals.
3.1.4. Steps should be taken to prevent the entry of unauthorised people. Areas
for processing, laboratory, storage, and quality control should not be used
as a right of way by personnel who do not work in them.
3.1.5. Facilities should permit ease of maintenance and cleaning. Open drains
should be avoided.
5. DOCUMENTATION
5.6. Specifications
5.6.1. There should be appropriately authorised and dated specifications for
starting and packaging materials, as well as finished blood and blood
components.
5.6.2. Specifications for starting and primary or printed packaging materials
should include or provide reference to, if applicable:
5.6.2.1. a description of the materials, including:
5.6.2.1.1. the designated name and the internal code reference;
5.6.2.1.2. the approved suppliers and, if reasonable, the original
producer of the material;
5.6.2.1.3 a sample of printed materials;
5.6.2.2. directions for sampling and testing;
5.6.2.3. qualitative and quantitative requirements with acceptance limits;
5.6.2.4 storage conditions and precautions;
5.6.2.5. the maximum period of storage before re-examination.
5.6.3. Specifications for in-process and finished components should be
available. Components should be labelled in accordance with legal
requirements.
5.8. Labelling
5.8.1. At all stages of the preparation, labelling should identify the individual
blood components and their nature clearly. The label on an intermediate
component should always allow the stage of processing to be determined
and should always include:
5.8.1.1. the name of the component;
5.8.1.2. the unique numeric or alpha-numeric donation identification;
5.8.1.3. the name of the producing blood establishment.
5.8.2 Preparation record: each unit is considered to be a unique batch, but
preparation records should provide sufficient information to build the
history and traceability of a prepared component. Usually this information
is captured in the computerised systems of the blood establishment. In
general, the blood establishment should have access to the following
processing records for each unit:
5.8.2.1. the name and unique identifier of the blood component;
5.8.2.2. the dates and times of commencement of significant
intermediate stages and of completion of processing:
5.8.2.3. the identification (initials) of the operator(s) who performed
each critical step of the process (including the process
controls) and, where appropriate, the name of any person who
verified such steps;
5.8.2.4. the batch number of any relevant consumables and/or
5.10. Sampling
5.10.1. There should be written procedures for sampling, which include the
methods and equipment to be used, the amounts to be taken, and any
precautions to be observed to avoid contamination of the material or any
deterioration in its quality.
5.10.2. Quality monitoring of blood components should be consistent with the
current specifications for in-process and finished components.
5.10.3. There should be written procedures for testing materials and blood
components at different stages of processing, describing the methods and
equipment to be used. The tests performed should be recorded.
5.11. Other
5.11.1. Written release and rejection procedures should be available.
5.11.2. Records should be maintained of the distribution of blood components to
6.8. Labelling
6.8.1. At all stages, all containers should be labelled with relevant information
on their identity. In the absence of a validated computerised system for
status control, the labelling should clearly distinguish released from non-
released units of blood and blood components.
6.8.2 Type of label to be used, as well as the labelling methodology, should be
suitable, and defined and established in written Standard Operating
Procedures.
6.8.3. Labels applied to containers, equipment or premises should be clear,
unambiguous and in the agreed format of the blood establishment.
6.8.4. Labelling system for collected blood, intermediate and finished blood
components, and samples should unmistakably identify the type of
content, and comply with the labelling and traceability legal requirements.
6.8.5. The label for a finished blood component should comply with the local,
national or regional regulatory requirements and contain at least the
following information:
6.8.5.1 the unique donation number; there should be traceability
through the use of this number to the donor and all records of
the processing steps to the final product
6.8.5.2 the product name;
6.8.5.3 the required storage conditions;
6.8.5.4 the expiry date and, where appropriate, time;
6.8.5.5 the date of collection of the donation(s) from which the blood
component was prepared and/or the production date and time
(where appropriate);
6.8.5.6 the ABO and RhD blood group (where appropriate); and
6.8.5.7 the name or other identification of the component preparation
site
6.8.6. Blood establishments responsible for the preparation of blood
components should provide the person(s) using the blood component with
information on their use, composition, and any special conditions that do
9.1. Deviations
9.1.1. Blood components deviating from required standards shall be released
for transfusion only in exceptional circumstances and with the recorded
agreement of the prescribing physician and the blood establishment
physician.
9.1.2. There should be a defined procedure for the release of non-standard
blood and blood components under a planned non-conformance system.
The decision for such release should be clearly documented and
authorised by a designated person and traceability should be ensured.
9.1.3. There should be systems in place to ensure that deviations, adverse
events, adverse reactions and non-conformances are documented,
carefully investigated for causative factors of any defect and, where
necessary, followed up by the implementation of corrective actions to
prevent recurrence.
9.1.4. The corrective and preventive actions (CAPAs) system should ensure that
existing component nonconformity or quality problems are corrected and
that recurrence of the problem is prevented.
9.1.5. Deviations from established procedures should be avoided as much as
9.2. Complaints
9.2.1. All complaints and other information, including serious adverse reactions
and serious adverse events that may suggest that defective blood
components have been issued, should be documented, carefully
investigated for causative factors of the defect and, where necessary,
followed up by recall and the implementation of corrective actions to
prevent recurrence. Procedures should be in place to ensure that the
Competent Authorities are notified, as appropriate, of serious adverse
reactions or serious adverse events in accordance with regulatory
requirements.
9.2.2. A person should be designated as responsible for handling complaints
and deciding the measures to be taken. This person should have sufficient
support staff. If this person is not the Responsible Person, the latter should
be made aware of any complaint, investigation or recall.
9.2.3. If a blood or blood component defect or testing error is discovered or
suspected, consideration should be given to checking related blood and
blood components in order to determine whether they are also affected.
9.2.4. All the decisions and measures taken as a result of a complaint should be
recorded. Complaint records should be reviewed regularly for any
indication of specific or recurring problems requiring attention and the
possible recall of distributed blood and blood components.
9.2.5. The Competent Authorities should be informed in cases of complaints
resulting from possible faulty processing, component deterioration or any
other serious quality problems, including the detection of counterfeiting.
F. GLOSSARY
Blood establishment
Any structure or body that is responsible for any aspect of the collection and testing of
human blood or blood components, whatever their intended purpose, and their
processing, storage, distribution if intended for transfusion. This does not include hospital
blood banks.
Calibration
Set of operations that establish, under specified conditions, the relationship between
values indicated by a measuring instrument/system or values represented by a material
measure and the corresponding known values of a reference standard.
Change control
A formal system by which qualified representatives of appropriate disciplines review
proposed or actual changes that might affect the validated status of facilities, systems,
equipment or processes. The intent is to determine the need for action that would ensure
and document that the system is maintained in a validated state.
Computerised system
A system comprising the input of data, electronic processing and the output of
information to be used either for reporting, automatic control or documentation.
Distribution
Act of delivery of blood and blood components to other blood establishments, hospital
blood banks, and manufacturers of blood- and plasma-derived products. It does not
include issuing blood or blood components for transfusion.
Donor
A person in normal health with a good medical history who voluntarily gives blood or
blood components for therapeutic use.
Donor deferral
Suspension of the eligibility of an individual to donate blood or blood components; such
suspension being either permanent or temporary.
Facilities
Hospitals, clinics, manufacturers and biomedical research institutions to which blood or
blood components may be delivered.
Good Practice
All elements in established practice that collectively lead to final blood or blood
components that consistently meet pre-defined specifications and compliance with
defined regulations.
Mobile site
A temporary or movable place used for the collection of blood and blood components
which is in a location outside of, but under the control of the blood establishment.
Procedure
A procedure controls a distinct process or activity, including the associated inputs and
outputs. A series of tasks usually performed by one person according to instructions.
Process
A set of related tasks and activities that accomplish a work goal.
Processing
Any step in the preparation of a blood component that is carried out between the
collection of blood and the issuing of a blood component.
Qualification
Part of validation: the action of verifying that any personnel, premises, equipment or
material works correctly and delivers the expected result.
Quality Assurance
All the activities from blood collection to distribution carried out with the objective of
ensuring that blood and blood components are of the quality required for their intended
use.
Quality control
Part of a quality system focused on fulfilling quality requirements.
Quality management
The coordinated activities to direct and control an organisation with regard to quality at
all levels within the blood establishment.
Quality monitoring
That part of a quality assurance programme concerned with maintenance and
improvement of quality which deals with the identification and use of indicators to detect
variations from standards or specifications.
Quality system
The organisational structure, responsibilities, procedures, processes, and resources for
implementing quality management.
Quarantine
The physical isolation of blood components or incoming materials/reagents over a
variable period of time while awaiting acceptance, issuance or rejection of the blood
Record
Written or electronically captured evidence that an event has occurred or an outcome
has been achieved. A document that contains objective evidence which shows how well
activities are being performed or what kind or results are being achieved.
Responsible person
The Responsible Person(s) should ensure that every unit of blood or blood component
has been collected, tested, processed, stored, and distributed in compliance with the
laws in force in that country and (if applicable) with the requirements of the Marketing
Authorisation. The Responsible Person(s) shall meet the qualification requirements laid
down in the national legislation, they shall be permanently and continuously at the
disposal of the blood establishment to carry out their responsibilities.
Risk assessment
Method to assess and characterize the critical parameters in the functionality of
equipment, systems or processes.
Specification
Description of the criteria that must be fulfilled in order to achieve the required quality
standard.
Validation
Refers to establishment of documented and objective evidence that the pre-defined
requirements for a specific procedure or process can be fulfilled consistently.
G. REFERENCES
Good Practice Guidelines for blood establishments and hospital blood banks,
Guide to the preparation, use and quality assurance of blood components,
Appendix to Recommendation No. R (95) 15, EDQM
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